A clinical trial to study the pain relief provided by a paravertebral block as compared to intravenous fentanyl alone for adult patients undergoing percutaneous nephrolithotomy (PCNL)surgery under general anaesthesia

TO STUDY THE ANALGESIC EFFICACY AND SAFETY PROFILE OF PARAVERTEBRAL BUPIVACAINE AS COMPARED TO INTRAVENOUS FENTANYL FOR ADULTS UNDERGOING PERCUTANEOUS NEPHROLITHOTOMY (PCNL) UNDER GENERAL ANAESTHESIA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/091/000101

Enrollment

Registered

2011-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N200- Calculus of kidney Health Condition 2: null- The study will be conducted in 50, ASA Grade I and II, patients aged 18-65years with kidney stones who are undergoing percutaneous nephrolithotomy under general anaessthesia.

Interventions

Intervention1: Paravertebral block: 20 ml of 0.5% bupivacaine will be administered through the paravertebral catheter prior to beginning the surgery. A bolus dose of 0.25% bupivacaine will be repeated

Eligibility

Inclusion criteria

Inclusion criteria: After obtaining institutional, ethics committee approval and informed written consent, the study will be conducted in 50, ASA Grade I and II, patients aged 18-65years undergoing percutaneous nephrolithotomy.

Exclusion criteria

Exclusion criteria: 1)Patients who refuse to participate in the study. 2)Patients with infection at the site of proposed block 3)Patients with severe chest wall deformity. 4)Patients having coagulopathy or receiving any anticoagulants. 5)Patients with known hypersensitivity to local anaesthetics. 6)Patients inability to understand the proper functioning and use of patient controlled analgesia (PCA) device due to any reason. 7)Patients who suffer from any intraoperative or postoperative complications like hydrothorax, urosepsis excessive bleeding, opposite side DJ stenting is done.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy and safety profile of paravertebral bupivacaine as compared to intravenous fentanyl alone in adult patients undergoing percutaneous nephrolithotomy (PCNL).Timepoint: In the intraoperative period heart rate (HR),non invasive blood pressure (NIBP) will be monitored every 5 minutes till skin incision and thereafter every 15 minutes. An increase in heart rate or mean blood pressure of more than 20% above baseline 0.5Âµg/kg IV fentanyl will be administered. In the recovery pain at rest and on deep breathing will be assessed using a visual analogue scale (0-10 cm) immediate postoperatively(0 hours) and at 1, 2, 4, 6, 12 and 24 hrs post operatively.	—

Measure

Time frame

To assess the efficacy and safety profile of paravertebral bupivacaine as compared to intravenous fentanyl alone in adult patients undergoing percutaneous nephrolithotomy (PCNL).Timepoint: In the intraoperative period heart rate (HR),non invasive blood pressure (NIBP) will be monitored every 5 minutes till skin incision and thereafter every 15 minutes. An increase in heart rate or mean blood pressure of more than 20% above baseline 0.5Âµg/kg IV fentanyl will be administered. In the recovery pain at rest and on deep breathing will be assessed using a visual analogue scale (0-10 cm) immediate postoperatively(0 hours) and at 1, 2, 4, 6, 12 and 24 hrs post operatively.

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Secondary

Measure	Time frame
To compare between the control group (fentanyl) and the study group (fentanyl+bupivacaine) 1.Intraoperative heart rate, mean arterial pressure. 2.intraoperative fentanyl requirement 3.incidence of postoperative nausea and vomiting (PONV). 4.peak expiratory flow rates (PEFR). 5. Analgesic consumed in ward (tramadol), 6.quality of recovery(QoR) and patient satisfaction 24 hours postop. Timepoint: intraoperative hemodynamic parameters (heart rate (HR), EKG, non invasive blood pressure (NIBP) every 5 minutes till skin incision, thereafter every 15 minutes till the end of surgery. Any haemodynamic response to skin incision will be noted. PEFR will be assessed at 6 hours and 24 hours postoperatively. QoR score and patient satisfaction at 24 hours postoperatively.	—

Measure

Time frame

To compare between the control group (fentanyl) and the study group (fentanyl+bupivacaine) 1.Intraoperative heart rate, mean arterial pressure. 2.intraoperative fentanyl requirement 3.incidence of postoperative nausea and vomiting (PONV). 4.peak expiratory flow rates (PEFR). 5. Analgesic consumed in ward (tramadol), 6.quality of recovery(QoR) and patient satisfaction 24 hours postop. Timepoint: intraoperative hemodynamic parameters (heart rate (HR), EKG, non invasive blood pressure (NIBP) every 5 minutes till skin incision, thereafter every 15 minutes till the end of surgery. Any haemodynamic response to skin incision will be noted. PEFR will be assessed at 6 hours and 24 hours postoperatively. QoR score and patient satisfaction at 24 hours postoperatively.

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Countries

India

Contacts

Public ContactAnuradha Borle

All India Institute of Medical Sciences

anjolie5@hotmail.com00911125220616

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026